A Medication Adherence Intervention for HIV Infected Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013065
First received: March 14, 2001
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.


Condition
HIV Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Medication Adherence Intervention for HIV Infected Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 210
Study Completion Date: December 2003

Detailed Description:

Background:

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Objectives:

Optimizing health for HIV patients requires excellent adherence to antiretroviral medication regimens. However, its unclear how best to incorporate adherence education and support programs into VA HIV outpatient care. We implemented and evaluated a pharmacist program (ACE) and a Pager reminder program to support adherence in veterans with HIV.

Methods:

We used a quasi-experimental design with pre-post evaluation at four VA Centers. Three treatment conditions (ACE, Pager, Usual Care) were rolled-in sequentially over two study phases, allowing for group comparisons between conditions. ACE is a multi-component manualized 4-session, individual patient education and support program by trained pharmacists. The Pager intervention used alphanumeric pagers to remind patients of dosing times. Electronically-monitored medication adherence (MEMS), self-report questionnaires, and pharmacy refill records were collected. Qualitative site interviews were collected before and after interventions to assist with program evaluation. Multilevel mixed models were used to analyze main study outcomes over time. Secondary analyses compared subgroup who actually received all ACE sessions (�as treated�) to controls.

Status:

Project has been completed and Final Report submitted to HSR&D CO.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must be greater than or equal to 18 years old, must be enrolled in HIV Primary care at one of 4 VA study sites and be taking antiretroviral therapy.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013065

Locations
United States, Arizona
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723-0001
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1207
VA San Diego Health Care System
San Diego, California, United States, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Allen L. Gifford, MD Edith Nourse Rogers Memorial Veterans Hospital, Be
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013065     History of Changes
Other Study ID Numbers: HII 99-054
Study First Received: March 14, 2001
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 14, 2014